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Label Adherence for Non-Vitamin K Antagonist Oral Anticoagulants in a Prospective Cohort of Asian Patients with Atrial Fibrillation
- Label Adherence for Non-Vitamin K Antagonist Oral Anticoagulants in a Prospective Cohort of Asian Patients with Atrial Fibrillation
- Lee, So-Ryoung; Lee, Young Soo; Park, Ji-Suck; Cha, Myung-Jin; Kim, Tae-Hoon; Park, Junbeom; Park, Jin-Kyu; Lee, Jung-Myung; Kang, Ki-Woon; Shim, Jaemin; Uhm, Jae-Sun; Kim, Jun; Kim, Changsoo; Kim, Jin-Bae; Park, Hyung Wook; Joung, Boyoung; Choi, Eue-Keun
- Ewha Authors
- SCOPUS Author ID
- Issue Date
- Journal Title
- YONSEI MEDICAL JOURNAL
- YONSEI MEDICAL JOURNAL vol. 60, no. 3, pp. 277 - 284
- Atrial fibrillation; non-vitamin K antagonist oral anticoagulant; drug labeling; dose
- YONSEI UNIV COLL MEDICINE
- SCIE; SCOPUS; KCI
- Document Type
- Purpose: Label adherence for non-vitamin K antagonist oral anticoagulants (NOACs) has not been well evaluated in Asian patients with non-valvular atrial fibrillation (AF). The present study aimed to assess label adherence for NOACs in a Korean AF population and to determine risk factors of off-label prescriptions of NOACs. Materials and Methods: In this COmparison study of Drugs for symptom control and complication prEvention of AF (CODE-AF) registry, patients with AF who were prescribed NOACs between June 2016 and May 2017 were included. Four NOAC doses were categorized as on- or off-label use according to Korea Food and Drug Regulations. Results: We evaluated 3080 AF patients treated with NOACs (dabigatran 27.2%, rivaroxaban 23.9%, apixaban 36.9%, and edoxaban 12.0%). The mean age was 70.5 +/- 9.2 years; 56.0% were men; and the mean CHA(2)DS(2)-VASc score was 3.3 +/- 1.4. Only one-third of the patients (32.7%) was prescribed a standard dose of NOAC. More than one-third of the study population (n=1122, 36.4%) was prescribed an off-label reduced dose of NOAC. Compared to those with an on-label standard dosing, patients with an off-label reduced dose of NOAC were older (>= 75 years), women, and had a lower body weight (<= 60 kg), renal dysfunction (creatinine clearance <= 50 mL/min), previous stroke, previous bleeding, hypertension, concomitant dronedarone use, and anti-platelet use. Conclusion: In real-world practice, more than one-third of patients with NOAC prescriptions received an off-label reduced dose, which could result in an increased risk of stroke. Considering the high risk of stroke in these patients, on-label use of NOAC is recommended.
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